Affiniti Diagnostic Ultrasound Systems: Software Versions 5 — Class II medical device recall Z-2484-2021
Completed recall by Philips Ultrasound Inc, reported 2021-09-29, distributed nationwide. Due to a software defect that can intermittently cause the system to lock-up which exiting Review Mode while p
| Recall number | Z-2484-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Ultrasound Inc, Bothell, WA, United States |
| Recall initiated | 2021-08-06 |
| Classified | 2021-09-17 |
| Reported by FDA | 2021-09-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BH, BO, BR, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DO, EC, EE, EG, ES, FI, FR, GB, GR, GT, HK, HN, HR, HU, ID, IE, IL, IN, IR, IT, JO, JP, KE, KR, KW, LB, LK, LT, LU, LV, MA, MX, MY, NG, NI, NL, NO, NP, NZ, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, RS, SA, SE, SG, SK, SV, TH, TN, TR, TW, UA, UY, VN, ZA |
| Quantity | 10,583 systems |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00884838056244, 00884838056251, 00884838074187, 00884838088658, 00884838097759, 00884838097766, 00884838097957 |
| Model numbers | 795118, 795119, 795121, 795208, 795210, 795218 |
Product
Affiniti Diagnostic Ultrasound Systems: Software Versions 5.0, 5.0.1 and 5.0.2 Models: Affiniti 30 795121 Affiniti 30 795218 Affiniti 50 795208 Affiniti 50 795118 Affiniti 70 795210 Affiniti 70 795119
Reason for recall
Due to a software defect that can intermittently cause the system to lock-up which exiting Review Mode while performing an exam.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2484-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.